FDA 510(k) Application Details - K152614

Device Classification Name	More FDA Info for this Device
510(K) Number	K152614
Device Name	Xpert Carba-R
Applicant	CEPHEID 904 CARIBBEAN DRIVE SUNNYVALE, CA 94089-1189 US Other 510(k) Applications for this Company
Contact	SCOTT A. CAMPBELL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2015
Decision Date	03/07/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review